Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2025-12-24 @ 11:53 AM
NCT ID:
NCT00093561
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Healthy participants in good medical condition
* No chronic medical conditions
* No regular use of prescription medications
* No evidence of psychiatric disorder
* Non-smoker
* Former smokers allowed provided they have not smoked within the past 3 months
* No history of alcohol abuse
* Serum lycopene concentration \< 700 nM
PATIENT CHARACTERISTICS:
Age
* 18 to 45
Performance status
* Karnofsky 100%
Life expectancy
* Not specified
Hematopoietic
* Hemoglobin ≥ 13.0 g/dL
* WBC ≥ 4,000/mm\^3
* Platelet count 150,000-400,000/mm\^3
Hepatic
* AST and ALT ≤ 75 U/L
* Bilirubin ≤ 2.0 mg/dL
* No liver disease
Renal
* Creatinine ≤ 1.5 mg/dL
* No renal disease
Cardiovascular
* No cardiovascular disease
* No abnormal EKG
Other
* Within 15% of ideal body weight
* No history of gastrointestinal malabsorption or other condition that would preclude drug absorption
* No alcohol consumption within the past 72 hours
* No allergy to tomato-based products
* No history of cancer
* No diabetes mellitus
* No other illness that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* At least 4 weeks since prior experimental drugs
* More than 14 days since prior prescription drugs
* No concurrent participation in another experimental trial
* No concurrent prescription drugs
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00093561
Study Brief:
Protocol Section:
NCT00093561